Heartware, Inc.: Heartware HVAD Pump Implant Kit, Product (REF) Number 1103

Is my product affected?

Heartware HVAD Pump Implant Kit, Product (REF) Number 1103

• UPC 00888707000017
• UPC 00888707002639
• UPC 00888707003261

Check against the official notice below — it lists the full affected range.

What happened

Heartware, Inc. is recalling 2,614 units of the Heartware HVAD Pump Implant Kit (product reference number 1103) distributed worldwide. The recall was issued because the outflow graft may tear and the strain relief screw may break during pre-implant pump assembly and attachment to the HVAD pump. The affected units are identified by two different GTINs with specific serial numbers ranging from HW26899 through HW31776.

The source document does not specify what consumers or healthcare providers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Details from the source

Reason for recall: The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. Distribution: Worldwide Distribution Quantity: 2614 units Lot/code info: GTIN 00888707000017, Serial Numbers: HW26899, HW27283, HW27893, HW28873, HW28999, HW29422, HW29488, HW29722, HW30166, HW30170 GTIN 00888707002639, Serial Numbers: HW29525, HW30015, HW30297, HW30477, HW31174, HW31179, HW31181, HW31246, HW31247, HW31250, HW31253, HW31257, HW31266, HW31268, hw31280, HW31281, hw31282, HW31283, HW31313, HW31385, HW31401, HW31497, HW31525, HW31526, HW31530, HW31531, HW31562, HW31567, HW31596, HW31597, HW31601, HW31602, HW31608, HW31609, HW31612, HW31624, HW31626, HW31634, HW31640, HW31641, HW31642, HW31643, HW31644, HW31645, HW31646, HW31647, HW31648, HW31649, HW31651, HW31652, HW31653, HW31655, HW31656, HW31657, HW31658, HW31659, HW31660, HW31661, HW31662, HW31663, HW31665, HW31666, HW31667, HW31668, HW31669, HW31670, HW31671, HW31672, HW31674, HW31675, HW31676, HW31677, HW31678, HW31679, HW31680, HW31681, HW31682, HW31687, HW31688, HW31689, HW31690, HW31691, HW31692, HW31693, HW31695, HW31696, HW31701, HW31705, HW31706, HW31707, HW31708, HW31709, HW31710, HW31711, HW31712, HW31713, HW31714, HW31716, HW31717, HW31719, HW31720, HW31721, HW31722, HW31723, HW31724, HW31725, HW31726, HW31728, HW31730, HW31732, HW31734, HW31736, HW31737, HW31738, HW31739, HW31740, HW31741, HW31742, HW31743, HW31744, HW31745, HW31746, HW31747, HW31748, HW31751, HW31752, HW31753, HW31754, HW31756, HW31757, HW31758, HW31760, HW31761, HW31762, HW31763, HW31764, HW31765, HW31766, HW31767, HW31768, HW31769, HW31770, HW31771, HW31772, HW31773, HW31774, HW31775, HW31776, HW317

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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